DE102009016150A1 - Atraumatic nasal tube for noninvasive respiratory support (NIV-CPAP) - Google Patents

Abstract

The invention relates to an atraumatic nasal tube (1) for non-invasive respiratory support (NIV-CPAP) comprising at least one central tube (5) extending from the bridge of the nose from the forehead to the nasal opening of the patient. The first end of the central tube (5) is equipped with an applicator (2) to be fixed to the forehead of the patient for connection to a breathing system coupled to a breathing machine, and the second end of the central tube (5) comprises nasal nozzles (6) which are sickle-shaped emerge from the central tube (5) and open into the nostril.

Description

The The invention relates to an atraumatic nasal tube for noninvasive Breath Support (NIV-CPAP).

at of mechanical ventilation or respiratory aid are those procedures referred to as non-invasive, in which the respiratory gas does not have an in the body the patient's penetrating endotracheal tube, a tracheostomy tube or a tracheostomy, but over a nasal tube is supplied.

One such nasal tube or nasal tube has two short nasal prongs, in the nostrils introduced become. Especially in premature babies Children come because of the extremely sensitive Nasal bridge and the nasal mucosa after prolonged lying time of the nose tube to inflammations, in severe cases also to necrotic changes in the nasal entry area.

When Cause for this Among other things to mention that all from the state of the art previously known nasal tubes a running opposite the nose bridge Have cross tube from which at an angle of 90 ° in one the thickness of the nasal nozzle adapted distance emerge the nasal prongs. In the worst case Case this cross tube is at the nose bridge and affects the Blood circulation, which ultimately leads to Nasenstegnekrosen. Equally, comes it inside the nose to injuries of the mucous membrane when the nasal prongs either too close or too far apart. For this reason are used by some manufacturers in the neonatal area (newborns) offered up to six different sizes, for an optimal adaptation to the geometric conditions of To ensure a nose.

The The object of the invention is now an atraumatic Nose tube for the non-invasive respiratory support to propose a high wearing comfort without the appearance of dermatitis or necrosis, which is easily adapted to differently trained Nasensepten and head shapes is customizable and the cost-effective to manufacture is.

According to the invention the atraumatic nose tube for the non-invasive respiratory support (NIV-CPAP) at least one central tube which is spaced from the bridge of the nose from the forehead to the nostril of the patient. The first end of the central tube is included with an applicator to be fixed to the forehead of the patient Connection of a hose system coupled to a respirator equipped, and the second end of the central tube comprises nasal prongs, which are sickle-shaped emerge from the central tube and open into the nostril.

One significant advantage of the invention is that through the crescent Design of the nasal prongs and that compared to the prior art missing Transverse tube no component is located directly opposite the nose bridge, whereby the formation of Nasenstegnekrosen structurally excluded is. Furthermore, the sickle shape has the advantage that the nasal prongs because of their big ones Length one have greater elasticity, which reduces the impact of force on the nasal septum will result in a decreased risk of nasal mucosa. Furthermore leads the curvature the nosepiece for greater flexibility, which bigger differences in the thicknesses of the nasal septum are bridged and less different tube sizes are needed.

By the modular design of the nose tube according to the invention becomes firstly the production considerably simplified. On the other hand, there is the possibility easily replace worn components with new components.

The Fixation of the applicator and thus indirectly also the central tube on the forehead of the patient is preferably done using a forehead pad, wherein the applicator relative to the forehead rest longitudinally in the direction the back of the nose and / or at an angle relative to the forehead support is adjustable.

The Connection between the forehead support and the applicator can thereby as frictional and / or positive be formed mechanical connection or through a connection done by magnetic force.

These mechanical connection allows a longitudinal adjustment and / or also an angular adjustment of the applicator to the forehead support.

In order to form a magnetic connection in the case of only one longitudinal adjustment, the forehead support and the applicator each have a magnetic section which is adapted to one another in a passable manner. It has proven to be particularly practicable if the applicator for this purpose has a circular, round, flat permanent magnet and the forehead support comprises a magnetic portion in the form of an oval, rectangle or an ellipse, which (s) in the front region of the patient along the bisector of the Patient extends so that a continuous height adjustment of the nose tube at different facial lengths can be particularly easily realized. Due to the magnetic connection can be a very simple and fast connection between the nose tube and the forehead support done.

The lateral surface of the central tube is preferably profiled at least partially formed, with the profile in the form of corrugation in the direction the longitudinal axis of the central tube, whereby the nose tube for the purpose of Adaptation to the natural curvature the upper half of the face the patient can be better elastically deformed. The ribbing can for the purpose of partial reduction of the wall thickness of the Central tube thereby formed on the top or bottom thereof be. For selected Use cases can The corrugations are also ring-shaped extend around the central tube.

The preferably made of plastic existing central tube has in cross section preferably a nearly rectangular profile with rounded edges, the ratio from width to height is about 2: 1.

at A first preferred embodiment of the invention comprises Central tube additionally embedded metal strips used for the purpose of adjusting the nose tube to the natural Curvature of the upper half of the face of the patient along with in the direction of the longitudinal axis the central tube extending ribbing a reversible deformability of the central tube. These embedded bendable metal strips are preferably arranged on the top or its bottom and cohesively firmly connected to the central tube, for example, they are with Plastic overmoulded. Instead of the bendable metal strips or -bleche can also be provided at least one wire core, the preferably in the wall of the end faces of the central tube extend in the longitudinal direction.

at a further preferred embodiment of the invention is dispensed with on the fixation of the desired Bending of the central tube by means of metal strips or wire cores and sees that one more extra Angle adjustment in the applicator before, by means of which the inclination opposite the central tube the forehead rest changed can be. This solution has the advantage that both the distance and the inclination of the Nasal tube according to the invention optimally to the geometric conditions between forehead support and nasal entry area can be adjusted. As a result of the highly elastic Central tube are thereby all the forces caused by the breathing tubes on the nostrils largely reduced.

In order to the nostrils opposite the nostrils can be fixed even better, becomes a positive fit provided on the second end of the central tube patch clamp. This contains fixation options for additional Ribbons that z. B. coming from the forehead rest, the central tube in the horizontal Fix direction.

Of the Applicator includes several connecting pieces for the supply and discharge of Media, for example, a connecting piece for the incoming inspiratory gas, a Connecting piece for the outflowing Expirationsgas, as well as a capped with a cap for a pressure measuring device. The aforementioned connecting pieces are - depending on the requirements - each preferably coupled with a hose, in turn, with a respirator are connected.

The feed medication by means of the nose tube according to the invention is preferably carried out using a connecting piece or medication connection, which by attaching an adapter to the tube of Inspiration branch is realized. The dosage of the appropriate medication takes place as needed. Optionally, the applicator such a connection piece include.

To the Purpose of length adjustment the nose tube and the connection between the central tube and applicator are the first end of the central tube and the connecting piece for the central tube of the applicator formed as a mating joint partners, wherein the inner contour of the first end of the central tube and the outer contour of the associated Connecting piece of the applicator are formed complementary to each other. In other words, the applicator can manually on the associated connection piece be attached to the central tube. By means of the other connecting pieces The applicator will connect to the inspiratory and expiratory Respiratory tube made.

Within the central tube of the atraumatic nose tube according to the invention, there is placed a median partition wall extending in the direction of its longitudinal axis which divides the central tube into a first flow chamber for the inspiration gas and into a second flow chamber for the expiration gas. This, a premature mixing of inspiratory gas and expiratory gas preventing partition extending from the first end of the central tube, ie directly between the connecting piece for the incoming inspiratory gas and the connecting piece for the outflowing expiratory gas, to about 5 to 15 mm before the second end of the central tube and ends there. However, a disadvantage of the partition wall is the associated increased rigidity of the nose tube compared to a desired bend. In an alternative embodiment is to avoid this Disadvantage the partition formed partially interrupted or is formed of a plurality of end faces spaced from each other webs. As has been shown in elaborate series of measurements, it is not to be expected in the geometric conditions of the central tube and the selected volume flows with a CO ₂ rebreathing, so that can be completely dispensed with the partition in a particularly simple embodiment of the invention.

The Nasal prongs preferably have annular reductions in wall thickness. This annular Reduction in wall thickness contribute to achieving greater elasticity of the nasal prongs at.

The Nostrils can a round or preferably one adapted to the shape of the nostril have triangular profile. When using a cross section triangular profile is connected to a larger exit surface with a lower flow resistance and a better seal against the nasal septum achieved.

at An advantageous development of the invention is reduced the inner cross section of the nasal prongs starting from the central tube until in the nostril placed mouth. It is thus prevented that due to the greater length of the nose piece of the flow resistance increases.

Of There is also the possibility in the region of the second end of the central tube a Klipphalter To provide as an angle adjustment, by means of which also the inclination of the central tube opposite the Forehead rest changed can be.

• • der nur aus wenigen Bauteilen modular aufgebaute Nasentubus ist kostengünstig herstellbar und leicht zu montieren,
• • durch die sichelförmige Gestaltung der Nasenstutzen und das gegenüber dem Stand der Technik fehlende Querrohr des Nasentubus befindet sich keine Komponente unmittelbar gegenüber dem Nasensteg, wodurch die Entstehung von Nasenstegnekrosen konstruktiv ausgeschlossen ist,
• • durch den im Stirnbereich des Patienten entlang der Kopfhalbierenden des Patienten sich erstreckenden magnetischen Abschnitt der Stirnauflage kann eine stufenlose Höhenverstellung des Nasentubus zur Anpassung an unterschiedliche Gesichtslängen besonders einfach realisiert werden,
• • durch die optionale Möglichkeit einer Winkelverstellung kann der Nasentubus auch bezüglich des Winkels an die Gesichtsgeometrie weitestgehend angepasst werden,
• • der Nasentubus ist unter Verwendung seines mehrere Anschlussstutzen aufweisenden Applikators mit verschiedenen Beatmungssystemen einsetzbar,
• • mittels der sich in Richtung der Längsachse des Zentralrohrs erstreckenden Riffelung und/oder der eingearbeiteten Drahtseelen kann der Nasentubus zum Zwecke der Anpassung an die natürliche Krümmung der oberen Gesichtshälfte des Patienten elastisch verformt werden,
• • der Applikator weist optional zusätzlich einen Anschlussstutzen bzw. eine Schnittstelle für Medikamente auf,
• • durch die Verwendung von im Querschnitt dreieckigen Profilen der Nasenstutzen wird eine größere Austrittsfläche, verbunden mit einem geringeren Strömungswiderstand und einer besseren Abdichtung gegenüber der Nasenscheidewand erzielt und
• • der Nasentubus weist optional einen im Bereich des Zentralrohrs oder Applikators platzierten Klipphalter auf, um seinen Einsatz auch bei agilen Babys zu ermöglichen.

The significant advantages and features of the invention over the prior art are essentially:

• • The nose tube, modularly constructed with just a few components, is inexpensive to produce and easy to assemble.
• • Due to the sickle-shaped design of the nosepiece and the lack of cross tube of the nose tube compared to the prior art, there is no component directly opposite the nose bridge, whereby the formation of Nasenstegnekrosen is structurally excluded,
• A continuous height adjustment of the nose tube for adaptation to different face lengths can be realized in a particularly simple manner by the magnetic section of the forehead support extending in the forehead region of the patient along the head bisector of the patient;
• • the optional possibility of an angle adjustment allows the nose tube to be adjusted as far as possible to the angle of the face geometry,
• The nasal tube can be used with various ventilator systems using its multi-port applicator,
• By means of the corrugation extending in the direction of the longitudinal axis of the central tube and / or of the incorporated wire cores, the nose tube can be elastically deformed for the purpose of adaptation to the natural curvature of the upper half of the face of the patient,
• • the applicator optionally has an additional connection port or an interface for medication,
• • By using triangular profiles of the nasal prongs, a larger exit area, combined with a lower flow resistance and a better seal against the nasal septum, is achieved and
• • The nasal tube optionally has a clip holder placed in the area of the central tube or applicator to allow its use even in agile babies.

The The aims and advantages of this invention are, after careful study the following detailed Description of the preferred, non-limiting example embodiments herein the invention with the associated Better understand and evaluate drawings. Of those show:

1 : a perspective view of the nose tube with clip holder for angle adjustment as a complete system,

2 : a perspective view of the nose tube with clip holder for angle adjustment and with additional forehead support immediately before mounting,

3 : A perspective view of the nose tube with clip holder for angle adjustment in cooperation with the forehead support in the ventilation state.

4 : a perspective view of the nose tube with magnetic adjustment as a complete system,

5 : an exploded view of the nose tube and mask

6.1 to 6.3 a forehead rest in different views.

The 1 illustrates an atraumatic nasal tube according to the invention 1 with additional angle adjustment as a perspective view for non-invasive respiratory support (NIV-CPAP). The nose tube 1 includes in the example shown a central tube 5 which extends from the bridge of the nose spaced from the frontal area to the nasal opening of the patient extends, wherein the first end of the central tube is equipped with an attached to the forehead of the patient applicator for connecting a coupled with a breathing machine hose system, and the second end of the central tube nosepiece 6 includes the crescent shape of the central tube 5 emerge and open in the nostril. The applicator 2 has a connection piece 3 for the inflowing inspiration gas, a connecting piece 4 for the outflowing expiration gas, a connecting piece 14 for the central tube 5 and two connecting pieces 13 for medication to be supplied. For the purpose of length adjustment of the nose tube 1 and for the purpose of coupling are the first end of the central tube 5 and the connecting piece 14 for the central tube 5 of the applicator 2 formed as a mating joint partners, wherein the inner contour of the first end of the central tube 5 and the outer contour of the connection piece 14 of the applicator 2 are formed complementary to each other. The lateral surface of the central tube 5 is at least partially profiled, with the profile in the form of a corrugation 12 in the direction of the longitudinal axis of the central tube 5 extends. This ribbing 12 includes transverse to the longitudinal axis of the central tube 5 extending material thickening or material recesses. This will, despite the fact that the central tube 5 made of an elastic plastic, achieves an even higher elasticity, so that the nose tube 1 can be optimally adapted to the natural curvature of the upper half of the face of the patient. Inside the central tube 5 is a median arranged in the direction of its longitudinal axis extending median partition wall 9 placed the central tube 5 in a first flow chamber 9.1 for the inspiratory gas and in a second flow chamber 9.2 divided for the expiration gas. This partition 9 Ends about 5 to 15 mm before the second end of the central tube 5 , The from the central tube 5 crescent-shaped emerging two nasal prongs 6 each have a shape adapted to the shape of the nostril triangular profile. The inner cross section of the nasal prongs 6 decreases starting from the central tube 5 to the mouth located in the nostril. Both nasal prongs 6 are substantially parallel to each other and extend - with the nose tube attached to the patient - starting from the second end of the central tube 5 over the tip of the nose up to the nostrils. The central tube 5 is formed in cross-section substantially rectangular with rounded edges, wherein the ratio of width to height is about 2: 1. In the area of the narrow end faces of the central tube 5 Both sides of a wire core are embedded or encapsulated in plastic to the central tube 5 To adapt to the curvature of the differently shaped upper facial halves of the patient to give a reversible deformability. For the purpose of angular adjustment is in the area of the applicator 2 a clip holder 15 placed, with the one hand, the length adjustment of the nose tube 1 on the face length and on the other hand, the inclination of the nose tube 1 for the purpose of adaptation to the curvature of the face of the patient can be realized.

The 2 shows a perspective view of the nose tube and the forehead support immediately prior to assembly, wherein the forehead support is placed on an indicated medical cap or cap of the patient and by means of which the forehead support 11 is locked indirectly on the head of the patient. Instead of the cap or cap may optionally be used with a Velcro strap, which is clamped around the head of the patient. The forehead rest 11 serves to fix the applicator 2 and thus the nose tube 1 on the forehead of the patient using said tape or a Velcro fastener 18 , The Velcro closure 18 forms a first fixed point of the nose tube 1 out. The second fixed point is formed by the sickle-shaped out of the central tube 5 leaking nasal prongs 6 according to the 3 and 4 achieved, which open in the nostril.

In the 3 is a perspective view of the nose tube 1 in cooperation with the forehead support 11 shown in the ventilation state. As can be seen, the nose tube according to the invention extends 1 from the forehead to the nasal opening of the patient. The nose tube 1 has particularly advantageous only two fixed points on the patient, namely a first fixed point in the region of the first end of the central tube 5 arranged applicator 2 and a second fixed point located at the second end of the central tube in the form of the two nasal prongs 6 is trained. Except for the nose opening in the nostril 6 none of the components of the nose tube according to the invention contacted 1 immediately the unprotected skin in the nasal entry area of the patient. This effectively prevents pressure sores and necroses. The nose tube, which nevertheless is arranged very close to the head of the patient 1 can be brought in a few steps in the desired position and to the different face shapes by a length adjustment and adjustment of the curvature of the central tube 5 be easily adapted.

For all previously described 1 to 3 includes the nose tube 1 a clip holder 15 as an angle adjustment, by means of which also the inclination of the central tube 5 opposite the forehead support 11 can be changed. This solution has the advantage that both the distance and the inclination of the nose tube according to the invention 1 optimally to the geometric relationships between the forehead support 11 and nasal entry area can be. As a result of the highly elastic central tube 5 As a result, all force effects on the part of the unillustrated breathing tubes to the nostrils are largely reduced. So that the nostrils 6 opposite to the nostrils can be fixed even better, is a positive fit to the second end of the central tube 5 attached clamp provided. This contains fixation options for additional bands that z. B. coming from the forehead rest, the central tube 5 also fix in horizontal direction.

The 4 shows a perspective view of the nose tube 1 with magnetic adjustment as a complete system. The nose tube 1 is essentially the same as in the 1 to 3 described nose tube 1 with the difference that here in the central tube 5 placed metal strips 7 or wire souls 8th are visible. The paired metal strips 7 or wire souls 8th in this case extend in the direction of the longitudinal axis of the central tube 5 , Another essential difference compared to the embodiment described above is that the forehead support 11 in the embodiment according to 4 no clip-holder 15 includes for angle adjustment. Rather, a magnetic connection is used, by means of which the applicator 2 on the forehead rest 11 is fixed. The magnetic connection is formed by a circular cross-section magnetic portion 10 , which is suitable for the magnetic section of the forehead rest 11 according to the 6.1 to 6.3 is. The magnetic section 10 the forehead rest 11 and the magnetic section 10 of the applicator 2 form as a magnetic connection a first fixed point of the nose tube 1 out. In an unillustrated embodiment of the invention is the magnetic section 10 the forehead rest 11 formed as an oval, ellipse or rectangle, which (s) extends in the frontal area along the bisector of the patient, so that a continuous height adjustment of the nose tube 1 can be realized at different face lengths.

The 5 shows an exploded view of the nose tube 1 , As essential features of the nose tube shown here 1 they are at the second end of the central tube 5 placed elastic mask 17 instead of the crescent-shaped nasal prongs 6 is used, as well as the connecting piece 16 to call for drug delivery, which is not directly on the applicator 1 but is arranged on an adapter piece in the inspiratory branch or inspiratory tube. The mask 17 is - as well as the nasal prongs 6 - directly with the central tube 5 connected, so from an assembly point of view when using this mask 17 , only the central tube 5 must be replaced, on which the desired components, namely the mask 17 or the nasal prongs 6 , optionally placed. These two different configurations are very clear the comparison between the 4 and 5 refer to.

The 6.1 to 6.3 illustrate a forehead rest 11 in different views. The forehead rest placed on a head cap or head cap 11 is formed substantially butterfly-shaped, wherein the two wings are curved according to the head shape of the patient. The curvature is achieved by the formation of the forehead support 11 made of plastic. Between the two wings is a cross-sectionally oval magnetic section 10 placed with the magnetic section 19 of the applicator 2 according to 5 corresponds, causing the applicator 2 on the forehead rest 11 is magnetically supported. Due to the oval version of the magnetic section 10 can the nose tube 1 special easy to be adjusted to the length of the patient's face. The wings further comprise (each) a hook-and-loop fastener which is locked to a cap to be placed on the patient's head or to a headband.

1

nasal tube

2

applicator

3

spigot for inspiration tube

4

spigot for expiratory hose

5

central tube

6

nose stub

7

metal strips

8th

wire core

9

partition wall

9.1

first flow chamber

9.2

second flow chamber

10

magnetic section

11

forehead support

12

knurl

13

cap for pressure gauge

14

spigot for pressure measuring device

15

clip holder

16

spigot for drug delivery

17

mask

18

velcro fastener

Claims (14)

Atraumatic nasal tube ( 1 ) for non-invasive respiratory support (NIV-CPAP), at least comprising a central tube ( 5 ) which extends from the bridge of the nose from the frontal area to the nasal opening of the patient, the first end of the central tube (Fig. 5 ) with an applicator to be fixed on the forehead of the patient ( 2 ) is fitted for connection of a hose system coupled to a respirator, and the second end of the central tube ( 5 ) Nosepiece ( 6 ), the sickle-shaped from the central tube ( 5 ) emerge and open in the nostril. Atraumatic nasal tube ( 1 ) according to claim 1, characterized in that the fixation of the applicator ( 2 ) on the forehead of the patient using a forehead support ( 11 ), wherein the applicator ( 2 ) relative to the forehead rest longitudinally in the direction of the nose back and / or at an angle relative to the forehead rest ( 11 ) is adjustable. Atraumatic nasal tube ( 1 ) according to one of claims 1 and 2, characterized in that the fixation of the applicator ( 2 ) on the forehead support ( 11 ) is carried out in a magnetic manner, wherein the forehead support ( 11 ) and the applicator ( 2 ) each have a magnetic section ( 10 ), which are adapted to each other. Atraumatic nasal tube ( 1 ) according to claim 3, characterized in that the magnetic section ( 10 ) of the forehead rest ( 11 ) is formed as an oval, ellipse or rectangle, which (s) extends in the front region of the patient along the bisector of the patient, so that a continuous height adjustment of the nose tube ( 1 ) can be realized at different face lengths. Atraumatic nasal tube ( 1 ) according to one of claims 1 to 4, characterized in that the lateral surface of the central tube ( 5 ) is profiled at least partially, wherein the profile in the form of a corrugation ( 12 ) in the direction of the longitudinal axis of the central tube ( 5 ), whereby the nose tube ( 1 ) can be elastically deformed for adaptation to the natural curvature of the upper half of the face of the patient. Atraumatic nasal tube ( 1 ) according to one of claims 1 to 5, characterized in that the central tube ( 5 ) embedded bendable metal strips ( 7 ) and / or a wire core ( 8th ) adapted for the purpose of fitting the nasal tube ( 1 ) to the natural curvature of the upper half of the patient's face a reversible deformability of the central tube ( 5 ) to ensure. Atraumatic nasal tube ( 1 ) according to one of claims 1 to 6, characterized in that the applicator ( 2 ) several connecting pieces ( 3 . 4 . 13 . 14 ) for the supply and discharge of media, for example a connecting piece ( 3 ) for the inflowing inspiration gas, a connecting piece ( 4 ) for the outflowing expiration gas, a connecting piece for the central tube ( 5 ), a connecting piece for a pressure measuring device ( 14 ) and a connector for drug delivery ( 16 ). Atraumatic nasal tube ( 1 ) according to one of claims 1 to 7, characterized in that for the purpose of length adjustment of the nose tube ( 1 ) the first end of the central tube ( 5 ) and the connecting piece ( 14 ) for the central tube ( 5 ) of the applicator ( 2 ) are formed as joining partners which can be displaced into one another, the inner contour of the first end of the central tube ( 5 ) and the outer contour of the connecting piece ( 14 ) of the applicator ( 2 ) are formed complementary to each other. Atraumatic nasal tube ( 1 ) according to one of claims 1 to 8, characterized in that within the central tube ( 5 ) a median arranged in the direction of its longitudinal axis median partition ( 9 ) is placed, which the central tube ( 5 ) into a first flow chamber ( 9.1 ) for the inspiratory gas and into a second flow chamber ( 9.2 ) divided for the expiration gas. Atraumatic nasal tube ( 1 ) according to claim 9, characterized in that the partition wall ( 9 ) about 5 to 15 mm in front of the second end of the central tube ( 5 ) ends. Atraumatic nasal tube ( 1 ) according to claim 9 or 10, characterized in that the partition wall ( 9 ) is formed partially interrupted or is formed only from a plurality of spaced-apart webs. Atraumatic nasal tube ( 1 ) according to one of claims 1 to 11, characterized in that the nasal prongs ( 6 ) have annular reductions in wall thickness. Atraumatic nasal tube ( 1 ) according to one of claims 1 to 12, characterized in that the nasal prongs ( 6 ) have a shape adapted to the shape of the nostril triangular profile. Atraumatic nasal tube ( 1 ) according to one of claims 1 to 13, characterized in that the inner cross-section of the nasal prongs ( 6 ) starting from the central tube ( 5 ) to the mouth located in the nostril.